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Targeted Treatments for Concussion

N/A

Recruiting

Led By Anthony Kontos, PhD

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at study completion, an average of 30 days after visit 1

Awards & highlights

No Placebo-Only Group

Summary

This trial tests targeted treatments for people 50+ with concussion, enrolling them at their first clinical visit and studying them up to 31 days later.

Who is the study for?

This trial is for adults aged 50 or older who have been diagnosed with a concussion within the last 4 days to 12 months. They must be able to read and write for assessments and are recruited at their initial concussion appointment. Those with neurological disorders, major psychiatric conditions other than depression/anxiety, or severe brain injuries/surgery are excluded.

What is being tested?

The study is testing targeted treatments for concussions in older adults through a randomized control trial. Participants will receive either behavioral control measures or specific interventions aimed at treating concussion symptoms, assessed during two clinic visits.

What are the potential side effects?

Since this trial involves behavioral controls and targeted interventions rather than medication, side effects may include discomfort from therapy sessions or emotional distress but should not involve physical drug-related side effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at study completion, an average of 30 days after visit 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at study completion, an average of 30 days after visit 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and at study completion, an average of 30 days after visit 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Concussion Clinical Profiles Screening (CP Screen)

Secondary study objectives

Dizziness Handicap Inventory (DHI)

General Anxiety Disorder-7 (GAD-7)

Headache Impact Test-6 (HIT-6)

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Targeted InterventionExperimental Treatment1 Intervention

Participant receives exercises or strategies based on their clinical concussion domain given to them by their neuropsychologist: 1) Anxiety/Mood, 2)Headache/Migraine, 3)Vestibular, 4)Ocular, 5)Cognitive.

Group II: Behavioral ControlActive Control1 Intervention

Participants randomized to the behavioral control group will receive standardized (i.e., all participants in this group will receive the same interventions) behavioral management strategies that include activity, hydration, nutrition, sleep, and stress management strategies.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Targeted Intervention

2015

N/A

~1440

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